Bill > HR946

This bill aims to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program, which is part of the Social Security Act. Orphan drugs are medications developed specifically to treat rare diseases or conditions that affect a small number of people. The bill makes two key changes: First, when calculating the time a drug has been on the market for potential price negotiation, the Secretary of Health and Human Services will no longer count the period during which the drug was classified as an orphan drug. Second, the bill modifies the definition of an orphan drug to allow drugs that treat one or more rare diseases or conditions, rather than just a single rare disease, to qualify for the exclusion. This change aligns with the definition of rare diseases found in the Federal Food, Drug, and Cosmetic Act. The overall effect is to provide more flexibility and protection for drugs developed to treat rare medical conditions in the context of government drug pricing negotiations.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/946/all-info